Nucleus
- Primary DI
- 09321502024938
- Brand
- Nucleus
- Company
- COCHLEAR LIMITED
- Model
- Z322475
- Catalog number
- Z322475
- Device description
- Cochlear EAC200 Series WaxStop Wax Management System
- Published
- 2014-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Contact Domains#
cochlear.comProduct Codes#
| Code | Name |
|---|---|
| PGQ | Hybrid cochlear implant |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| PGQ | Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification | Unknown | 3 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| P130016 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 09321502024938 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 09321502024938 | 09321502024938 | 9321502024938 |
GMDN Terms#
| Term | Definition |
|---|---|
| Cochlear implant system | A battery-powered assembly of devices [cochlear implant (CI)] intended for the partial restoration of auditory sensation to a severely/profoundly deaf person. It consists of an inner electrode array implanted in one cochlea and connected to a receiver-stimulator implanted near the ear; and an externally worn microphone-sound processor, battery pack, coil cable, and coil (transmitter). Sound waves are converted into electrical signals by the sound processor (transducer) and sent to the coil (transmitter) via the coil cable. The coil transmits the signals to the receiver-stimulator and ultimately to the cochlea via the electrode array. Dedicated implantation instruments may be included. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)523-5798 | customer@cochlear.com |
Regulatory Flags#
- DUNS number
- 750551194
- Device count
- 1
- No natural rubber latex
- true
Other Devices From This Company#
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|---|---|---|---|---|
| 09321502053082 | Cochlear® Nucleus® Nexa™ cochlear implant with Slim Straight electrode | CI1022 | Z334204 | 2025-07-07 |
| 09321502053099 | Cochlear® Nucleus® Nexa™ cochlear implant with Slim Modiolar electrode | CI1032 | P1434929 | 2025-07-07 |
| 09321502053105 | Cochlear® Nucleus® Nexa™ cochlear implant with Slim 20 electrode | CI1024 | P1549674 | 2025-07-07 |
| 09321502069847 | Cochlear® Nucleus® Nexa™ cochlear implant | CI1012 | P1979576 | 2025-07-07 |
| 09321502014564 | Cochlear® Nucleus® CI512 cochlear Implant | CI512 | Z209051 | 2014-09-24 |
| 09321502032599 | Cochlear® Nucleus® CI522 cochlear Implant with Slim Straight electrode | CI522 | Z382660 | 2016-09-20 |
| 09321502032612 | Cochlear® Nucleus® CI532 cochlear Implant with Slim Modiolar electrode | CI532 | Z285654 | 2016-09-20 |
| 09321502046329 | Cochlear® Nucleus® CI624 cochlear implant with Slim 20 electrode | CI624 | P1431676 | 2020-02-18 |
| 09321502036573 | Cochlear® Nucleus® CI622 cochlear Implant with Slim Straight electrode | CI622 | P783829 | 2019-07-12 |
| 09321502036580 | Cochlear® Nucleus® CI632 cochlear Implant with Slim Modiolar electrode | CI632 | P783831 | 2019-07-12 |
| 09321502036818 | Cochlear® Nucleus® CI612 cochlear Implant | CI612 | P774600 | 2019-07-12 |
| 09321502046459 | Cochlear | P1624218 | P1624218 | 2020-01-03 |
| 09321502046466 | Cochlear | P1624188 | P1624188 | 2020-01-03 |
| 09321502046473 | Cochlear | P1624189 | P1624189 | 2020-01-03 |
| 09321502046480 | Cochlear | P1624190 | P1624190 | 2020-01-03 |
| 09321502046497 | Cochlear | P1624191 | P1624191 | 2020-01-03 |
| 09321502039864 | Nucleus® 7 Processing Unit | CP1000 | Z544559 | 2017-07-07 |
| 09321502063692 | Cochlear™ Personalisation Cover | P1840531 | P1840531 | 2022-11-30 |
| 09321502063715 | Cochlear™ Personalisation Cover | P1840591 | P1840591 | 2022-11-30 |
| 09321502066815 | Cochlear™ Microphone Cover | P1878176 | P1878176 | 2022-11-29 |
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